Tomosynthesis vs. Contrast-Enhanced Mammography in Women With Personal History of Breast Cancer in Western Pennsylvania

NCT ID: NCT04085510

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1647 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-23
• Study Completion Date: 2027-06-30

Brief Summary

This is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false-positives, in women with a personal history of breast cancer.

Detailed Description

The investigators expect to show in a prospective clinical trial that, in women with a personal history of breast cancer, contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false positives. The investigators expect a substantial increase in node-negative invasive cancers in particular. Because DBT will be interpreted first by one reader, and CEM will be interpreted first, and independently, by a second reader, there will also be an assessment of performance of tomosynthesis alone or CEM alone in this population. Participants will be invited to three rounds of annual screening with CEM. CEM must be performed at the time of or within 6 weeks of routine annual mammogram with tomosynthesis.

Conditions

Breast Cancer Female; Breast Cancer; Breast Neoplasms; Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Contrast-enhanced mammogram

All women will receive both 3D mammography and contrast-enhanced mammography for breast cancer screening; the order of interpretation will vary for each of two radiologists

Group Type: EXPERIMENTAL

Contrast-enhanced mammogram

Intervention Type: DEVICE

Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion.

Interventions

Contrast-enhanced mammogram

Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

-Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment.

Exclusion Criteria

• Women with a history of prior iodinated contrast reaction
• Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions)
• Women who have had bilateral mastectomy
• Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 30 mL/min
• Pregnancy or lactation
• Women actively being treated for cancer of any type with chemotherapy
• Lump or other breast symptoms
• Abnormality on prior breast imaging that is being followed.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Breast Cancer Research Foundation

OTHER

Sponsor Role: collaborator

Wendie Berg

OTHER

Sponsor Role: lead

Responsible Party

Wendie Berg

Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wendie Berg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee Womancare Passavant Cranberry

Cranberry Township, Pennsylvania, United States

Magee Womancare Monroeville

Monroeville, Pennsylvania, United States

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY19060359

Identifier Type: -

Identifier Source: org_study_id